Category Access to Medicine

Can Negotiations at the World Health Organization Lead to a Just Framework for the Prevention, Preparedness and Response to Pandemics as Global Public Goods?

[Viviana Muñoz Tellez] This paper advances that WHO Member States, having agreed to the objectives of advancing equity and solidarity for future pandemic prevention, preparedness and response, now must operationalize these. The paper offers suggestions for the ongoing WHO processes of: 1) review of recommendations under examination by the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies, 2) consideration of potential amendments to the International Health Regulations (IHR) 2005, and 3) elaboration of a draft text for an international instrument on pandemic preparedness and response.

Access To Medicines and Pharmaceutical Patents: Fulfilling The Promise of TRIPS Article 31bis

[Ezinne Miriam Igbokwe and Andrea Tosato] Abstract: ... The most contentious [TRIPS] issue has long been the impact of the TRIPS patents regime on access to medicines. Our Article contributes to this debate by illuminating an oft-overlooked facet of TRIPS: Article 31bis. Enacted following the Doha Declaration of 2001, this provision was designed to enable Members with inadequate manufacturing capabilities to import patented pharmaceuticals produced by generics manufacturers under an export compulsory license (ECL) issued by another Member. Initially welcomed with enthusiasm, ECLs have enjoyed minimal success. We propose an explanation for the current fallow state of Article 31bis and suggest approaches to fulfill its promise.

A Review of WTO Disputes on TRIPS: Implications for Use of Flexibilities for Public Health

[Nirmalya Syam] The use of TRIPS flexibilities by WTO members involves interpretation of the obligations under TRIPS which can be challenged under the WTO dispute settlement system. Mutually agreed solutions, panel or Appellate Body decisions adopted in such disputes can thus impact the scope of TRIPS flexibilities to address, among others, public health objectives. This paper explores how the WTO dispute settlement system applies to disputes under TRIPS, and reviews the outcomes of the disputes relating to the implementation of TRIPS obligations in the context of pharmaceutical products.

The Right to Health in Pharmaceutical Patent Disputes

[Emmanuel Kolawole Oke] This paper examines how the courts in three developing countries (Kenya, South Africa, and India) have addressed the tension between patent rights on pharmaceutical products and the right to health. The paper begins by examining the nature of the relationship between patent rights and the right to health. It thereafter explores the justiciability of the right to health in Kenya, South Africa, and India. Furthermore, the paper provides an analysis of how the courts in these three developing countries have adjudicated some of the pharmaceutical patent cases involving tensions between the right to health and patent rights. The paper contends that by incorporating the right to health into the adjudication of patent disputes, courts in developing countries can play a crucial role in improving access to medicines at affordable prices.

Mainstreaming Public Health Considerations in Adjudication of Intellectual Property Disputes: Implications of Specialized IP Courts and General Courts

[Justice (Retd.) Prabha Sridevan] How can the public interest dimension be considered in the adjudication of intellectual property (IP) disputes, in particular those concerning patents on health technologies such as medicines and vaccines? This is the main question addressed by Justice (Retd.) Prabha Sridevan, former Judge of the Madras High Court and former Chairperson of the Intellectual Property Appellate Board (IPAB) of India, as an expert facilitator, at the Asian Regional Course for Judges on Intellectual Property and Public Health organized by the South Centre in August 2021. Justice Sridevan addressed the pros and cons of adjudication through specialized courts vis-à-vis general courts.

Utilising Public Health Flexibilities in the Era of COVID-19: An Analysis of Intellectual Property Regulation in The OAPI and MENA Regions of Africa

[Yousuf A. Vawda and Bonginkosi Shozi] Abstract: The paper explores the unique approaches to IP protection in the countries belonging to the Organisation Africaine de la Propriété Intellectuelle/African Intellectual Property Organization (OAPI) and the Middle East and North Africa (MENA) regions; the limited extent to which legal and policy frameworks with regard to TRIPS flexibilities have been adopted and implemented in pursuit of access to medicines in those countries; and makes recommendations in order to optimise the use of the flexibilities in advancing public health objectives. In the context of the COVID-19 pandemic, the impact of IP rights on access, and some approaches to countering the challenges to access are also discussed.

Vaccines, Medicines and COVID-19: How Can WHO Be Given a Stronger Voice?

[Germán Velásquez] The considerable health, economic and social challenge that the world faced in early 2020 with COVID-19 continued and worsened in many parts of the world in the second half of 2020 and into 2021. How can an agency like WHO be given a stronger voice to exercise authority and leadership? This book is a collection of research papers produced by the author between 2020 and early 2021 that helps answer this question. The topics address the state of thinking and debate – particularly with regard to medicines and vaccines – that would enable a response to this pandemic or subsequent crises that may emerge.

Competition Law and Access to Medicines: Lessons from Brazilian Regulation and Practice

[Matheus Z. Falcão, Mariana Gondo and Ana Carolina Navarrete] Competition law may play an important role in drug pricing control by containing high prices derived from economic violations. Since the use of competition tools is not limited by the TRIPS Agreement or other international binding disciplines, there is ample policy room to explore how countries, especially in the Global South, can benefit from strengthening their jurisdiction on that matter.

Vaccine Knowledge Needs to Be a global Public good

[Ellen 't Hoen] The global health crisis caused by the COVID-19 outbreak has laid bare the lack of an effective mechanism for the sharing of IP and technology required to produce the diagnostics, therapeutics and vaccines to respond to the pandemic. The WHO established, in May 2020, well before the first vaccines came to market, the COVID-19 Technology Access Pool (C-TAP): a mechanism to allow the sharing of the IP, knowhow, data and technology that are needed to meet the global need for 11 billion doses of COVID-19 vaccines, as well as diagnostics and treatments. Companies have so far refused to collaborate with C-TAP, citing the age-old talking point that sharing IP is detrimental to future investments in pharmaceutical innovations – even though the development of COVID-19 vaccines has been de-risked with unprecedented amounts of public financing.

Access to COVID-19 Vaccines in High-, Middle-, and Low-Income Countries Hosting Clinical Trials

[Reshma Ramachandran, Joseph S. Ross, and Jennifer E. Miller] The COVID-19 pandemic has led to the rapid development of multiple vaccines, tested in clinical trials located in several countries. Low- and middle-income countries have experienced significant delays in vaccine access despite initiatives aiming to ensure fair distribution, such as COVID-19 Vaccines Global Access (COVAX). Because pharmaceuticals do not receive consistent and timely authorization for use in lower-income countries where they are tested, we examined authorization and delivery of COVID-19 vaccines recommended by the World Health Organization (WHO) in the countries where they were tested.

Pfizer and The Medicines Patent Pool (MPP) Sign Licensing Agreement for COVID-19 Oral Antiviral Treatment Candidate to Expand Access in Low- and Middle-Income Countries

[MPP Press Release] Pfizer and the Medicines Patent Pool (MPP), a United Nations-backed public health organization working to increase access to life-saving medicines for low- and middle-income countries, today announced the signing of a voluntary license agreement for Pfizer’s COVID-19 oral antiviral treatment candidate PF-07321332, which is administered in combination with low dose ritonavir (PF-07321332; ritonavir). The agreement will enable MPP to facilitate additional production and distribution of the investigational antiviral, pending regulatory authorization or approval, by granting sub-licenses to qualified generic medicine manufacturers, with the goal of facilitating greater access to the global population.

Research Exceptions in Comparative Copyright Law

[Sean Flynn, Michael Palmedo, and Andrés Izquierdo] Abstract: Recent scholarship has highlighted the positive impact on scholarship of copyright exceptions for text and data mining and of more “open” exceptions for research uses. Until now, however, there has not been a collection and categorization of the world’s copyright laws according to the degree to which they provide exceptions for research. In this report, we release the results of the first such study. We show that every copyright law in the world has at least one exception to promote research uses of copyrighted works, but that such exceptions vary widely between countries.